Note: Descriptions are shown in the official language in which they were submitted.
CA 02737640 2016-03-24
MEDICAL DEVICE SECUREMENT SYSTEM
RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Patent
Application No. 61/098,704, titled "MEDICAL DEVICE SECUREMENT SYSTEM",
filed September 19, 2008.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This invention relates to a securement system used to attach a
catheter or other medical article to a patient.
Description of the Related Art
[0003] It is common in the treatment of patients to utilize catheters
to
introduce fluids and medications directly into the patient or to withdraw
fluids from the
patient. Often, it becomes desirable to maintain such catheterization over an
extended
period of time during the treatment of a patient. In order to keep the
catheter or other
medical line properly positioned for the duration of treatment, the catheter
or medical
line can be secured to the patient in a variety of ways. Most commonly, this
involves
taping the catheter or medical line to the patient.
[0004] Securing a catheter with tape upon the patient traditionally has
certain drawbacks. The use of tape at the insertion site can retain dirt or
other
contaminant particles, potentially leading to infection of the patient. Tape
also fails to
limit catheter motion and, therefore, contributes to motion related
complications like
phlebitis, infiltration and catheter migration. Additionally, removal of taped
dressings
can itself cause undesired motion of the catheter upon the patient.
[0005] Taped dressings also require periodic changes. The frequent,
often
daily, removal and reapplication of adhesive tape to the skin of the patient
can
excoriate the skin in the area around the dressing. Such repeated applications
of tape
over the catheter or medical line can additionally lead to the build up of
adhesive
residue on the outer surface of the catheter or medical line. This residue can
result in
contaminants adhering to the catheter itself, increasing the likelihood of
infection of
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the insertion site. This residue can also make the catheter or medical line
stickier and
more difficult to handle for healthcare providers.
SUMMARY OF THE INVENTION
[0006] The systems and methods of the present invention have several
features, no single one of which is solely responsible for its desirable
attributes.
Without limiting the scope of this invention as expressed by the claims which
follow,
its more prominent features will now be discussed briefly. After considering
this
discussion, and particularly after reading the section entitled "Detailed
Description of
the Preferred Embodiments" one will understand how the features of this
invention
provide several advantages over traditional catheter securement systems.
[0007] One aspect of the present invention is a securement system for
securing a medical article to the skin of a patient. The system comprises a
medical
article having a connector fitting and a catheter hub and two anchor pads.
Each anchor
pad is spaced apart from the other and has a lower surface at least partially
covered by
an adhesive for contacting the patient's skin. The system further includes a
retainer
that has a body member. The body member has a channel formed therethrough
about a
channel axis, the channel being configured to retain at least a first portion
of the
medical article and having a first longitudinal access opening disposed on an
underside
of the body member to allow at least ingress of the first portion of the
medical article
into the channel. The retainer further includes two support members. Each
support
member is attached to one of the anchor pads and configured to support the
body
member. Each support member is spaced apart from the channel axis so as not to
obstruct at least ingress of the first portion of the medical article into the
channel. The
retainer further includes a first abutment surface extending generally normal
to the
channel axis and configured to inhibit longitudinal movement of the medical
article in
a first longitudinal direction. The system further includes a clamp extending
distally
from a distal surface of the retainer. The clamp has a collar configured to
surround at
least 180 degrees of the at least a second portion of the medical article. The
collar has
a second longitudinal access opening disposed on an underside of the collar to
allow at
least ingress of the second portion of the medical article into the collar.
The second
longitudinal access opening is aligned with the first longitudinal access
opening. The
clamp further includes a second abutment surface extending generally normal to
the
channel axis and configured to inhibit longitudinal movement of the medical
article in
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a second longitudinal direction opposite the first longitudinal direction. The
system
further includes interengaging structure configured to couple the clamp and
the retainer
and to allow movement of the clamp relative to the retainer in at least the
first
longitudinal direction, wherein movement of the clamp relative to the retainer
in the
first longitudinal direction moves the second abutment surface closer to the
first
abutment surface.
100081 Another aspect of
the present invention is a device for securing a
medical article to a patient. The device includes two anchor pads. Each anchor
pad is
spaced apart from the other and has a lower surface at least partially covered
by an
adhesive for contacting the patient's skin. The device further includes a
retainer that
has a body member. The body member includes a channel formed therethrough
about
a channel axis. The channel is configured to retain at least a first portion
of the
medical article and has a first longitudinal access opening disposed on an
underside of
the body member to allow at least ingress of the first portion of the medical
article into
the channel. The device further includes two support members. Each support
member
is attached to one of the anchor pads and configured to support the body
member.
Each support member being spaced apart from the channel axis so as not to
obstruct at
least ingress of the first portion of the medical article into the channel.
The device
further includes a first abutment surface extending generally normal to the
channel
axis. The first abutment surface is configured to abut a corresponding first
surface of
the medical article and inhibit longitudinal movement of the medical article
in a first
longitudinal direction. The device further includes a clamp extending distally
from a
distal surface of the retainer. The clamp has a collar configured to surround
at least
180 degrees of the at least a second portion of the medical article. The
collar has a
second longitudinal access opening disposed on an underside of the collar to
allow at
least ingress of the second portion of the medical article into the collar.
The second
longitudinal access opening being aligned with the first longitudinal access
opening.
The clamp further includes a second abutment surface extending generally
normal to
the channel axis, the second abutment surface configured to abut a
corresponding
second surface of the medical article and inhibit longitudinal movement of the
medical
article in a second longitudinal direction opposite the first longitudinal
direction. The
device further includes interengaging structure configured to couple the clamp
and the
retainer and to allow movement of the clamp relative to the retainer in at
least the first
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longitudinal direction, wherein movement of the clamp relative to the retainer
in the
first longitudinal direction moves the second abutment surface closer to the
first
abutment surface.
[00091 Another aspect of the invention is a device for securing a medical
article to a patient. The device includes a retainer having a channel formed
therethrough about a channel axis, the channel being configured to receive a
first
portion of the medical article and having a first longitudinal access opening
disposed
on an underside of the retainer. The device further includes two supports
supporting
the retainer. Each support is disposed on opposite sides of the channel axis
so as to
allow at least ingress of the first portion into the channel. The device
further includes a
clamp extending distally from a distal surface of the retainer. The clamp has
a collar
sized and shaped to surround at least 180 degrees of a second portion of the
medical
article. The collar has a second longitudinal access opening disposed on an
underside
of the clamp to allow at least ingress of the second portion of the medical
article into
the collar. The second longitudinal access opening being generally aligned
with the
first longitudinal access opening. The device further includes interengaging
structure
coupling the clamp and the retainer so as to allow movement of the clamp
relative to
the retainer in a longitudinal direction and inhibit movement of the clamp
relative to
the retainer in a direction opposite to the longitudinal direction.
[00101 Another aspect of the invention is a method of securing a medical
article to a patient, the medical article having a first distally-facing
abutment surface
and a first proximally-facing abutment surface. The method includes providing
a
securement device comprising a retainer, a clamp extending distally from a
distal
surface of the retainer, and interengaging structure configured to couple the
retainer to
the clamp. Each of the retainer and clamp form a channel having a truncate
cross-
sectional shape. Each channel has an access opening dispose so as to face a
patient's
skin, the channel of the clamp sized and shaped to surround at least 180
degrees of the
medical article. The method further includes locating the securement device
above the
medical article so as to align portions of the medical article with the
channels of the
securement device, pressing the portions of the medical article through the
access
openings and into the channels so as to limit movement of the medical article
in at
least lateral and transverse directions relative to the securement device, and
moving the
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clamp toward the retainer so as to limit movement of the medical article in a
longitudinal direction relative to the securement device.
[0011] These and other features of the present invention will become
readily apparent to those skilled in the art from the following detailed
description of
the preferred embodiments, which refers to the attached figures. The invention
is not
limited, however, to the particular embodiments that are disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGURE 1 is a perspective view of a securement system in
accordance with a preferred embodiment of the present invention, illustrating
a
cooperating clamp and retainer supported by a pair of anchor pads.
[0013] FIGURE 2 is a top plan view of the securement system illustrated
in
FIGURE 1.
[0014] FIGURE 3 is a top plan view of the clamp and retainer from
FIGURE 1 with arms of the clamp extending through corresponding slots in the
retainer.
[0015] FIGURE 4 is a bottom plan view of the clamp and retainer of
FIGURE 3 and shows a channel configured to receive a portion of a medical
article.
[0016] FIGURE 5 is a front view of the clamp and retainer of FIGURE 3.
[0017] FIGURE 6 is a rear view of the clamp and retainer of FIGURE 3.
[0018] FIGURE 7 is a side view of the clamp and retainer of FIGURE 7.
[0019] FIGURE 8 is a front perspective view of the retainer from FIGURE
3 without the clamp.
[0020] FIGURE 9 is a rear perspective view of the retainer of FIGURE 8.
[0021] FIGURE 10 is a top plan view of the retainer of FIGURE 8.
[0022] FIGURE 11 is a bottom plan view of the retainer of FIGURE 8.
[0023] FIGURE 12 is a front view of the retainer of FIGURE 8.
[0024] FIGURE 13 is a rear view of the retainer of FIGURE 8.
[0025] FIGURE 14 is a side view of the retainer of FIGURE 8.
[0026] FIGURE 15 is a cross-sectional view of the retainer taken through
line 15-15 of FIGURE 10 and shows an abutment surface configured to abut
against a
surface of a secured medical article.
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[0027] FIGURE 16 is a cross-sectional view of the retainer taken through
line 16-
16 of FIGURE 10 and shows a beam defining a surface of the slot and configured
to engage
with the arm of the clamp.
[0028] FIGURE 17 is a top perspective view of the clamp from FIGURE 3
removed from the retainer.
[0029] FIGURE 18 is a bottom perspective view of the clamp of FIGURE 17
and
shows a series of teeth on each arm that engage with the beam illustrated in
FIGURE 16.
[0030] FIGURE 19 is a top plan view of the clamp of FIGURE 17 and shows
an
inwardly extending protrusion on each arm that cooperates with a stop in the
slot of the
retainer to inhibit longitudinal proximal movement of the clamp beyond a
particular position
during fabrication assembly and shipping.
[0031] FIGURE 20 is a bottom plan view of the clamp of FIGURE 17.
[0032] FIGURE 21 is a rear view of the clamp of FIGURE 17 and shows a
collar
disposed so as to abut a surface of a secured medical article.
[0033] FIGURE 22 is a front view of the clamp of FIGURE 17.
[0034] FIGURE 23 is a cross-sectional view taken through line 23-23 of
FIGURE
3, illustrating the clamp engaged with the retainer with the clamp in a distal
most position.
[0035] FIGURE 24 is an exploded perspective view of the securement system
shown in FIGURE 1 prior to inserting an exemplary medical article into the
clamp and
retainer.
[0036] FIGURE 25 is a view similar to FIGURE 24 except that the medical
article
is received in both the retainer and clamp.
[0037] FIGURE 26 is a view similar to FIGURE 25 except that the clamp is
advanced in a proximal direction toward the retainer to secure the medical
article
therebetween and inhibit movement of the medical article in both the proximal
and distal
directions.
[0038] FIGURE 27 is a perspective view of a securement system according
to
another preferred embodiment of the present invention, illustrating a
cooperating clamp and
retainer supported by a pair of anchor pads.
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[0039] FIGURE 28 is a top plan view of the securement system illustrated
in
FIGURE 27.
[0040] FIGURE 29 is a top plan view of the clamp and retainer from FIGURE
27
with arms of the clamp extending through corresponding slots in the retainer.
[0041] FIGURE 30 is a bottom plan view of the clamp and retainer of
FIGURE
27 and shows a channel configured to receive a portion of a medical article.
[0042] FIGURE 31 is a front view of the clamp and retainer of FIGURE 29.
[0043] FIGURE 32 is a rear view of the clamp and retainer of FIGURE 29.
[0044] FIGURE 33 is a side view of the clamp and retainer of FIGURE 29.
[0045] FIGURE 34 is a cross-sectional view of the clamp and retainer
taken
through line 34-34 of FIGURE 33 and shows beams defining a surface of the
slots engaged
with the arms of the clamp.
[0046] FIGURE 35 is a. front perspective view of the retainer from FIGURE
29
without the clamp.
[0047] FIGURE 36 is a rear perspective view of the retainer of FIGURE 35.
[0048] FIGURE 37 is a top plan view of the retainer of FIGURE 35.
[0049] FIGURE 38 is a bottom plan view of the retainer of FIGURE 35.
[0050] FIGURE 39 is a front view of the retainer of FIGURE 35.
[0051] FIGURE 40 is a rear view of the retainer of FIGURE 35,
[0052] FIGURE 41 is a side view of the retainer of FIGURE 35.
[0053] FIGURE 42 is a cross-sectional view of the retainer taken through
line 42-
42 of FIGURE 37, and shows an abutment surface configured to abut against a
surface of a
secured medical article.
[0054] FIGURE 43 is a top perspective view of the clamp from FIGURE 29
without the retainer and shows a series of teeth on each arm that engage with
the beams
illustrated in FIGURE 34.
[0055] FIGURE 44 is a bottom perspective view of the clamp of FIGURE 43.
[0056] FIGURE 45 is a top plan view of the clamp of FIGURE 43 and shows
an
outwardly extending protrusion on each arm that cooperates with a stop in the
slot of the
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=
retainer to inhibit longitudinal proximal movement of the clamp beyond a
particular position
during fabrication, assembly and shipping.
[0057] FIGURE 46 is a bottom plan view of the clamp of FIGURE 43.
[0058] FIGURE 47 is a rear view of the clamp of FIGURE 43 and shows a
collar
disposed so as to abut a distal facing surface of a secured medical article.
[0059] FIGURE 48 is a front view of the clamp of FIGURE 43.
[0060] FIGURE 49 is an exploded perspective view of the securement system
shown in FIGURE 27 prior to inserting an exemplary medical article.
[0061] FIGURE 50 is a view similar to FIGURE 49 except that the medical
article
is received in a channel of the retainer.
[0062] FIGURE 51 is a view similar to FIGURE 50 except that the clamp is
advanced in a proximal direction toward the retainer to secure the medical
article
therebetween and inhibit movement of the medical article in both the proximal
and distal
directions
[0063] FIGURE 52 is a perspective view of a securement system according
to
another preferred embodiment of the present invention, illustrating a
cooperating clamp and
retainer supported by a pair of anchor pads securing an exemplary medical
article.
[0064] FIGURE 53 is a top plan view of the securement system illustrated
in
FIGURE 52, shown without the medical article.
[0065] FIGURE 54 is a side view of the clamp and retainer of FIGURE 53
without the anchor pads.
[0066] FIGURE 55 is a cross-sectional view of the clamp and retainer of
FIGURE
54 taken through line 55-55 of FIGURE 54 and shows beams the engagement of the
arms of
the clamp with the retainer.
[0067] FIGURE 56 is a front perspective view of the retainer from FIGURE
54
with the clamp removed.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0068] The following description and the accompanying figures, which
describe
and show the preferred embodiments, are made to demonstrate several possible
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configurations that a securement system can take to include various aspects
and features of
the invention. The illustrated embodiments are shown in use with an
illustrative example of
a medical article that includes a catheter hub and extension set nut. For
example,
embodiments of the retainer may be used with Smiths Medical AdvantIV and
Protect1V
catheters. However, the securement system may be used with other catheter
designs. The
illustration of the securement device in this context is not intended to limit
the disclosed
aspects and features of the invention to the specified embodiments or to usage
only with the
illustrated medical article. Those of skill in the art will recognize that the
disclosed aspects
and features of the invention are not limited to any particular embodiment of
a securement
system, and securement systems, which include one or more of the inventive
aspects and
features herein described, can be designed for use with a variety of medical
articles (or
combinations of medical articles) of varying design. One skilled in the art
may also find
additional applications for the devices and systems disclosed herein.
[0069] To assist in the
description of these components of the securement system,
the following coordinate terms are used (see FIGURE 1). A "longitudinal axis"
is generally
parallel to a portion of the medical article retained by the securement
system, as well as
parallel to the axis of a channel of the retainer, through which the medical
article extends. A
"lateral axis" is normal to the longitudinal axis. A "transverse axis" extends
normal to both
the longitudinal and lateral axes. In addition, as used herein, "the
longitudinal direction"
refers to a direction substantially parallel to the longitudinal axis; "the
lateral direction" refers
to a direction substantially parallel to the lateral axis; and "the transverse
direction" refers to
a direction substantially parallel to the transverse axis. The term "axial" as
used herein refers
to the axis of the channel or connector fitting, and therefore is
substantially synonymous with
the term "longitudinal" as used herein. Also, the terms "proximal" and
"distal", which are
used to describe the present securement system, are used consistently with the
description of
the exemplary applications (i.e., the illustrative example of the use
application). Thus,
proximal and distal are used in reference to the center of the patient's body.
The terms
"upper," "lower," "top," "bottom," "underside," "upperside" and the like,
which also are used
to describe the present securement system, are used in reference to the
illustrated orientation
of the embodiment. For example, the term "upperside" is used to describe the
portion of the
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retainer that is located above a lateral axis that passes through the axis of
the channel. The
term "underside" is used to describe the portion of the retainer that is
located below a lateral
axis that passes through the axis of the channel. Brief introductions to some
of the features,
which are common to the described embodiments of the securement systems, are
now
described.
[0070] The securement system described herein is especially adapted to
arrest
transverse, lateral, and/or longitudinal movement of a medical article, such
as a catheter, as
well as to stabilize and hold the medical article against the patient. As
described below,
retention mechanisms to accomplish these goals include, among others,
retention and/or
abutment surfaces located on a retainer which receives the medical article,
retention and/or
abutment surfaces of a clamp which cooperates with the retainer and/or with
the medical
article itself, as well as a ratcheting mechanism by which the clamp may be
tightened against
the retainer. The ratchet mechanism allows a single securement system to be
used with
medical articles that have different longitudinal lengths. In some
embodiments, the
securement system is adapted to secure the medical article as close to the
insertion site as
possible, while also providing a low profile and maintaining a desired
insertion angle, for
example, 7 degrees between the needle and patient's skin. In some embodiments,
the
securement system is adapted to allow stable securement of a variety of
medical articles of
differing dimensions.
[0071] In some embodiments, a securement system generally includes two
parts, a
retainer and a clamp. The retainer includes a longitudinal channel configured
to receive and
secure at least a portion of a medical article. The longitudinal channel has a
longitudinal
access opening to allow ingress and egress of the medical article. The
retainer also includes
at least one support that is preferably disposed on the underside of the
retainer at a position
lower than the access opening. In some embodiments, the support includes left
and right
mounting wings that are integral with the body of the retainer and that are
attached to left and
right anchor pads. The lower surfaces of the left and right anchor pads attach
to the patient's
skin.
[0072] In some embodiments, the retainer includes one or more abutments,
preferably an abutment surface, which cooperates with at least one contact
point or surface on
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the medical article. The one or more abutments of the retainer extend
generally normal to the
longitudinal axis and can be, for example, but without limitation a surface, a
wall of a slot, a
ridge, a protuberance, a lip of a clip, or like structures. The abutment
cooperates with the one
or more contact points or surfaces of the medical article to inhibit
longitudinal movement of
the medical article through the retainer.
[0073] The securement system includes interengaging structure that
secures the
clamp to the retainer. For example, one of the clamp and retainer may include
at least one
arm that engages with corresponding structure of the other one of the clamp
and retainer so as
to secure the clamp relative to the retainer. When the clamp and the retainer
are engaged, the
arm can extend generally along a side of the channel of the retainer as is
illustrated in Figure
1. Of course more than one arm may be employed and or disposed so as to extend
along the
top or bottom of the channel between the clamp and the retainer.
[0074] In some embodiments, the clamp includes one or more abutments,
preferably an abutment surface that cooperates with at least one contact point
or surface on
the medical article. The one or more abutments of the clamp extend generally
normal to the
longitudinal axis when the clamp is engaged with the retainer and can be, for
example, but
without limitation a surface, a wall of a slot, a ridge, a protuberance, a lip
of a clip, or like
structures. The one or more abutments of the clamp can face in a generally
opposing
direction to the retainer abutment, so as to cooperate with a contact point or
surface on the
medical article that faces in a generally opposing direction to the contact
point or surface that
cooperates with the retainer abutment. The clamp can be movable with respect
to the retainer
in at least a longitudinal direction, such that the abutments of the clamp and
retainer can be
moved closer together (or farther apart) to accommodate medical articles of
varying
dimensions.
[0075] The clamp and retainer can include corresponding interengaging
structure
so that their respective abutment surfaces can be securely tightened against
the corresponding
surfaces of medical articles of varying dimensions. The clamp and the retainer
thus
cooperate to inhibit at least longitudinal movement of the medical article
through the retainer.
In some embodiments, the clamp includes a collar having at least one abutment
surface which
extends generally parallel to the longitudinal axis when the clamp is engaged
with the
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retainer. The abutment surface of the collar can have a flat or a curved
shape, and can be
configured to correspond to a surface of a portion of the medical article. The
collar
cooperates with the corresponding surface the medical article so as to limit
transverse and/or
lateral movement of the medical article at least when the clamp and retainer
are tightened
around the medical article. With this construction, the retainer can hold the
retained portion
of medical article in a secure and stable manner, close to the patient's skin,
when the retained
portion is positioned within the channel, while avoiding chafing or
excoriating the skin.
[0076] With reference
now to FIGURE 1, a securement system 100 generally
includes a retainer 102 and a clamp 104. The retainer 102 and clamp 104
include
interengaging structure. The body of the retainer 102 includes a
longitudinally-extending
channel 106 which is configured to receive at least a portion of a medical
article. The
channel 106 can have a constant or variable cross section, such as a taper,
along a portion or
all of its length, and can be configured to roughly match the cross section of
the portion of the
medical article which it is adapted to retain.
[0077] The channel 106
is capable of receiving a portion or length of the medical
article and is generally configured to house, to preferably grip, and to
secure this portion of the
medical article. In the illustrated embodiment an inner surface contour of the
channel 106
preferably is selected depending on the geometry of the portion of the medical
article to be
retained. For example, in a retainer 102 that is configured to retain a
portion of a medical
article that has a constant outer diameter, the channel preferably has a
constant radius along
its length. In contrast, in a retainer 102 configured to retain a portion of a
medical article that
has a tapering outer surface, the channel preferably has a tapering inner
surface and a radii
that varies along the channel length. Additional embodiments of the channel
106 of the
retainer can comprise a plurality of different radii and/or tapering regions.
In this way, the
size and shape of the channel 106 can be chosen to match or to approximate the
size and
shape of the medical article or portion thereof, e.g., the catheter hub, to be
retained. By
matching the inner surface contour of the channel 106 to the outer surface of
the secured
portion of a medical article, a more effective securement may be achieved. In
addition or in
the alternative, effective securement can also be achieved by the engagement
of one or more
abutment surfaces of the retainer 102 and clamp 104 with one or more contact
surfaces on the
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medical article. These contact surfaces may include, for example, a proximally-
facing
surface 152 and a distally-facing surface 154 of the medical article. Each
abutment surface
can cooperate with a contact surface on the medical article to inhibit
movement of the
medical article relative to the retainer and/or clamp.
[0078] The channel 106
can extend through an arc of greater than 1800, so as to
provide a degree of snap-fit between the retainer 102 and the medical article.
The channel
106 has a longitudinal access opening 108 located on an underside of the
retainer 102, to
allow ingress or egress of the medical article. To facilitate placement of the
medical article in
the channel 106, the retainer 102 can include one or more features, such as a
depression
above the channel 106 and/or a groove disposed within the channel 106, which
effectively
thin a wall of the retainer 102 near the channel 106 to provide some degree of
flexibility
about the opening 108. The medical article can be installed or removed from
the underside of
the retainer via this access opening 108. Such an arrangement allows the
medical provider to
align at least a portion of the medical article with the retainer 102 prior to
fixing the retainer
to the patient's skin near an insertion site 180 (indicated by an "X" in
FIGURE 1).
[0079] The illustrated
retainer 102 includes two supports 110(a), 110(b) disposed
on a lower portion of the retainer 102. The supports 110(a), l I 0(b) can be
disposed at a
position lower than the access opening 108, so as to limit or prevent contact
of the retained
portion of the medical article with the skin of the patient. The supports
110(a), 110(b) are
disposed on a pair of anchor pads 112(a), 112(b). The supports 110(a), 110(b)
and the
anchor pads 112(a), 112(b) are spaced apart so as to allow ingress and egress
of the medical
article therebetween. The anchor pads 112(a), 112(b) can have an adhesive
disposed on their
undersides so as allow attachment of the pads 112(a), 112(b) to the skin of a
patient. In the
illustrated embodiment, the arrows on the retainer 102 point in the direction
toward the
insertion site (i.e., in the proximal direction).
[0080] Each anchor pad
112(a), 112(b) desirably comprises a laminate structure
with an upper plastic, paper or foam layer (e.g., closed-cell polyethylene
foam) and a lower
adhesive layer. The lower adhesive layer constitutes a lower surface of the
anchor pad. The
lower surface desirably is a medical-grade adhesive and can be either
diaphoretic or
nondiaphoretic, depending upon the particular application. Such foam with an
adhesive layer is
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available commercially from Avery Dennison of Painsville, Ohio. While not
illustrated, the
anchor pads can include suture holes in addition to the adhesive layer to
further secure the
anchor pad to the patient's skin.
[0081] In other variations, a hydrocolloid adhesive or zinc oxide-based
adhesive
can advantageously be used upon the anchor pads 112(a), 112(b) for attaching
the anchor
pads to the skin of the patient. The hydrocolloid or zinc oxide-based adhesive
can be used
either alone or in combination with another medical grade adhesive (e.g., in
combination with
the adhesive available from Avery Dennison). Hydrocolloid and zinc oxide-based
adhesives
have less of a tendency to excoriate the skin of a patient when removed. This
can be
particularly important for patients whose skin is more sensitive or fragile,
such as neonates
and those with a collagen deficiency or other skin related condition.
[0082] In another variation, each anchor pad 112(a), 112(b) comprises a
laminate
structure with an upper woven layer and a lower adhesive layer. The upper
layer can be
polyester or other suitable polymer or textile materials. One particular
suitable material is
woven polyester available commercially under the name "Tricot" from Tyco. The
lower
adhesive layer constitutes the lower surface of the anchor pad. The lower
surface desirably is
a medical-grade adhesive and can be either diaphoretic or nondiaphoretic,
depending upon
the particular application.
[0083] A surface of the upper foam layer constitutes an upper surface of
the
anchor pads 112(a), 112(b). The upper surface can be roughened by corona-
treating the foam
with a low electric charge. The roughened or porous upper surface can improve
the quality of
the adhesive joint (which is described below) between the supports 110(a),
110(b) and the
anchor pads 112(a), 112(b). In a further variation, the flexible anchor pad
can comprise an
upper paper or other woven or nonwoven cloth or plastic layer in lieu of a
roughened upper
foam surface.
[0084] A removable paper or plastic release liner desirably covers the
adhesive
lower surface before use. The liner preferably resists tearing and desirably
is divided into a
plurality of pieces to ease attachment of the pad to a patient's skin. The
liner comprises a
folded over portion to define a pull tab. The pull tab can be utilized to
remove the paper or
plastic release liner from their adhesive lower surface before use. A medical
provider uses
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the pull tab by grasping and pulling on it so that the liner is separated from
the lower surface.
The pull tab overcomes any requirement that the medical provider pick at a
corner edge or
other segment of the liner in order to separate the liner from the adhesive
layer.
[0085] The pull tab of course can be designed in a variety of
configurations. For
example, the pull tab can be located along a center line of the anchor pad; or
alternatively, the
pull tab can be located along any line of the anchor pad in order to ease the
application of the
anchor pad onto the patient's skin at a specific site. For example, an area of
a patient's skin
with an abrupt bend, such as at a joint, can require that the pull tab be
aligned toward one of
the lateral ends of the anchor pad rather than along the center line.
[0086] The retainer 102 also includes one or more slots 114(a), 114(b)
disposed
on one or more sides of the channel 106. The illustrated embodiment includes
two slots
114(a), 114(b). The slots 114(a), 114(b) are configured to receive and engage
with at least
portion of the clamp 104, as will be described in further detail below. In the
illustrated
embodiment, the slots 114(a), 114(b) extend in a longitudinal direction
through the body of
the retainer 102, and are angled slightly downward in the proximal direction
relative to the
patient's skin. In some embodiments, the slots extend only partway through the
body of the
retainer 102. Each slot 114(a), 114(b) has a length sufficient to support an
arm 116(a),
116(b) of the clamp 104 and maintain the angle of the clamp 104 with respect
to the retainer
102 (and thus, with respect to the skin of the patient) when the clamp 104 is
engaged with the
retainer 102.
[0087] The clamp 104 includes one or more arms 116(a), 116(b) configured
for
insertion into and engagement with the one or more slots 114(a), 114(b). The
illustrated
embodiment includes two arms 116(a), 116(b). The arms 116(a), 116(b) are
connected at
their distal ends by a collar 118. The collar 118 includes a proximally-facing
surface 120
which abuts a corresponding, distally-facing surface of the medical article
when it is received
in the retainer 102 and the clamp 104 is tightened with the retainer 102. The
collar 118 also
includes a curved, inwardly-facing surface 122 which contacts an outer surface
of the medical
article when the medical article is secured in the system 100. The surface 122
can extend
about the medical article through an arc of less than, about, or greater than
180 so as to
inhibit lateral and/or transverse motion of the medical article to the extent
desired. Each of
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the arms 116(a), 116(b) includes one or more ratchet teeth 124 which are
configured to
engage corresponding structure of the retainer 102, as will be described in
further detail
below.
[0088] FIGURE 2 shows a plan view of the securement system 100. As can be
seen in the figure, the arms 116(a), 116(b) extend from the collar 118
generally parallel to
one another. In some embodiments, the arms can extend at an angle, toward each
other or
apart from each other, in a generally longitudinal direction.
[0089] FIGURES 3 and 4 are top and bottom plan views, respectively, of
the
clamp 104 and retainer 102 shown in FIGURE 1. As can be seen in FIGURE 4, the
channel
106 includes a distally-facing abutment surface separated into two abutment
surfaces 126(a),
126(b) by a narrow groove. At least one of the abutment surfaces 126(a),
126(b) is
configured to abut a corresponding, proximally-facing surface of the medical
article when the
medical article is received in the channel 106 and when the clamp 104 is
tightened with the
retainer 102, so as to inhibit longitudinal movement of the medical article in
at least a
proximal direction.
[0090] As can also be seen in FIGURE 4, the interengaging structure of
the
retainer 102 includes at last one beam 128(a), 128(b). The beam 128(a), 128(b)
is disposed
laterally of the channel 106, near the slots 114(a), 114(b). The illustrated
beams 128(a),
128(b) are cantilevered beams that extend from a distal portion of the
retainer 102 toward a
proximal portion of the retainer 102. The beams 128(a), 128(b) can be
configured to flex
with respect to the portion of the retainer 102 to which they are attached, so
as to facilitate
engagement and/or disengagement of the clamp 104 with the retainer 102.
[0091] FIGURES 5 through 7 show front, rear, and side views,
respectively, of
the clamp 104 and retainer 102 of FIGURE 3. As most clearly shown in FIGURE 7,
an axis
of the central channel 106 lies at an angle 0 with respect to the base
surfaces of the retainer
102. The desired angle 0 between the medical article and the patient is
created by angling the
axis of the central channel 106. This angle is selected in order to align the
axis of the channel
106 of the retainer with the desired incident angle with which the medical
article is to contact
the skin of the patient. A variety of different angles can be used, ranging
from 00 to 45 , and
more preferably from 50 to 25 . For instance, for the seeurement of
intravenous catheters, it
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is desirable for the angle of incidence or 0 of the catheter to the skin of
the patient to be
between about 7 to about 150. For the securement of arterial catheters, it is
desirable for the
angle of incident of the catheter to the skin of the patient to be about 12.5
. By angling the
axis of the channel 106 at the desired angle 0, which will depend upon the
particular
securement application (e.g., securing an arterial catheter, an intravenous
catheter, etc.), the
proper angle of incidence for a catheter can be maintained.
[0092] FIGURES 8 and 9
show front and rear perspective views, respectively, of
the retainer 102 of FIGURE 3. As can be seen in FIGURE 8, each beam 128(a),
128(b)
includes one or more locking teeth 130(a), 130(b). When the arms 116(a),
116(b) of the
clamp 104 are inserted into the corresponding slots 114(a), 114(b) of the
retainer 102, the
ratchet teeth 124 and the locking teeth 130(a), 130(b) cooperate inside the
slots 114(a),
114(b) to adjustably secure the longitudinal position of the clamp 104 with
respect to the
retainer 102.
[0093] As can be seen
in FIGURE 9, the retainer 102 can also include one or
more stops 132 disposed in or near the slots 114(a), 114(b). The stops 132 can
be configured
to cooperate with one or more protrusions 134 on the arms 116(a), 116(b) to
inhibit
longitudinal proximal movement of the clamp beyond a selected position during
fabrication
assembly and shipping. Of course the stops 132 and the protrusions 134 are not
necessary to
engage the clamp 104 with the retainer 102.
[0094] FIGURES 10 and
11 show top and bottom plan views, respectively, of the
retainer 102 of FIGURE 8. FIGURES 12 through 14 show front, rear, and side
views,
respectively, of the retainer 102 of FIGURE 8.
[0095] FIGURE 15 is a
cross-sectional view of the retainer 102 taken through line
15-15 of FIGURE 10 and shows an abutment surface 126(b) configured to abut
against a
surface of a secured medical article. Although the channel 106 can be formed
in various
shapes depending upon the desired application (e.g., depending upon a shape of
the retained
portion of the medical article for which the retainer is designed to be used),
the channel 106
desirably has a sufficient length in the longitudinal direction to stabilize
the connector fitting,
catheter hub, or other medical article, rather than act as a fulcrum for the
fitting. That is, the
retainer 102 receives a sufficient length of the medical article to inhibit
movement of the
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article in the lateral, longitudinal and transverse direction (i.e., to
inhibit yaw, pitch and axial
movement of the article).
[0096] FIGURE 16 is a
cross-sectional view of the retainer taken through line 16-
16 of FIGURE 10 and shows the beam 128(6) defining a surface of the slot
114(b) and
configured to engage with the arm 116(b) of the clamp 104.
[0097] FIGURE 17 is a
top perspective view of the clamp 104 from FIGURE 3
without the retainer 102. FIGURE 18 is a bottom perspective view of the clamp
104 of
FIGURE 17 and shows a series of teeth 124 on each arm 116 that engage with the
beam 128
illustrated in FIGURE 16. As can be seen in the figures, the clamp 104 can
include one or
more protrusions 134. The protrusions 134 cooperate with the motion stops 132
of the
retainer 102 to slightly inhibit longitudinal movement of the clamp 104 beyond
a particular
position when the clamp 104 is engaged with the retainer 102 during
fabrication and
assembly. For example, the protrusions 134 can be disposed on the arms 116(a),
116(b) of
the clamp 104 such that, when the clamp 104 is inserted into the retainer 102
and the
protrusions 134 abut the motion stops 132 during assembly, only a single
ratchet tooth 124
passes over the locking tooth 130(a), 130(b) of each flex beam 128(a), 128(b).
Such an
arrangement may be beneficial during shipment by inhibiting the clamp 104 from
closing
against the retainer 102 while keeping the clamp 104 secured to the retainer
102.
[0098] With the
application of some degree of force, however, the protrusions
134 (and thus, the clamp 104) can be moved past the motion stops 132 in order
to close (or
tighten) the clamp 104 in the direction of the retainer 102. During use, a
medical provider
simply pushes the clamp 104 in a proximal direction passing the protrusions
134 by the stops
132 until the medical article is secured between the opposing abutment
surfaces on the clamp
and retainer. By such a configuration, the protrusions 134 and the motion
stops 132
cooperate to prevent self-closing of the system 100 during assembly and
shipping but still
allow the medical provider to secure a medical article during use.
[0099] FIGURE 19 is a
top plan view of the clamp of FIGURE 17 and shows the
inwardly extending protrusion 134 on each arm configured to cooperate with the
stop 132 in
the slot of the retainer to inhibit longitudinal proximal movement of the
clamp beyond a
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particular position during fabrication assembly and shipping. FIGURE 20 is a
bottom plan
view of the clamp of FIGURE 17.
[0100] FIGURE 21 is a rear view of the clamp 104 of FIGURE 17 and shows a
collar disposed so as to abut a surface of a secured medical article. FIGURE
22 is a front
view of the clamp of FIGURE 17.
[0101] FIGURE 23 is a cross-sectional view of the embodiment shown in
FIGURE 1, taken through line 23-23 of FIGURE 3, and illustrates the engagement
of the
clamp 104 with the retainer 102. As the arms 116(a), 116(b) are inserted into
the slots
114(a), 114(b), the leading edges of the arms 116(a), 116(b) abut the locking
teeth 130(a),
130(b) of the retainer 104. With gentle force applied in the proximal the
direction, the arms
116(a), 116(b) can advance further into the slots 114(a), 114(b), as the
cantilevered beams
128(a), 128(b) flex downward to allow successive engagement of the ratchet
teeth 124. By
such a configuration, the collar 118 can be moved closer to the retainer 102
and secured at
any desired distance from the retainer.
[0102] The securement system 100 illustrated in FIGURES 1-23 is
configured for
single-use applications, and thus does not include a mechanism by which the
clamp 104 may
be easily released from the retainer 102 after the clamp 104 and retainer 102
have been
tightened about a medical article. In some embodiments, however, a release
mechanism can
be included to allow for release and retraction of the clamp from the
retainer. Such a
mechanism can comprise, for example, one or more tangs which extend laterally
from the
flex beams to a point laterally beyond a portion of the retainer. To release
the clamp in such
an embodiment, the tangs can be depressed to disengage the locking tooth of
the flex beam
from the ratchet teeth of the clamp, allowing the clamp to be easily retracted
(in a distal
direction) from the slots and removed from the retainer if desired. In some
such
embodiments, the clamp can be provided with one or more stop members
configured to
prevent complete separation of the clamp from the retainer.
[0103] Further, although the embodiment illustrated includes ratchet
teeth on the
clamp arms and locking teeth on the retainer, alternative embodiments can of
course include
a reverse configuration in which ratchet teeth are provided on the retainer
and one or more
locking teeth are provided on an arm or arms of the clamp. Of course, the
clamp and the
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retainer can include any other suitable corresponding structure that allows
relative motion of
the clamp and the retainer in a longitudinal direction, while providing
securement of their
relative positions as desired.
[0104] Although the embodiment illustrated includes arms extending from
the
clamp, alternative embodiments can of course include a reverse configuration
in which the
arms extend from the retainer and slide within slots in the clamp.
[0105] FIGURE 24 is an exploded perspective view of the embodiment shown
in
FIGURE 1, shown with an exemplary medical article 150 prior to being received
in the
retainer 102. The medical article has a proximally-facing surface 152, a
distally-facing
surface 154, and at least one outwardly-facing surface 156.
[0106] FIGURE 25 shows the exemplary medical article 150 received in the
channel 106 of the retainer 102, prior to insertion of the arms 116(a), 116(b)
into the slots
114(a), 114(b). In this position, the abutment surfaces 126(a), 126(b) inside
the channel 106
(see FIGURE 4) cooperate with the proximally-facing surface 152 of the medical
article 150
to inhibit longitudinal movement of the article 150 in a proximal direction
beyond a desired
position.
[0107] FIGURE 26 shows the clamp 104 engaged with the retainer 102, with
the
two parts tightened together about the medical article 150. In the illustrated
secured position,
the proximally-facing surface 120 of the clamp 104 cooperates with the
distally-facing
surface 154 of the medical article 150 to inhibit longitudinal movement of the
article 150 in a
distal direction beyond a desired position, and the inwardly-facing surface
122 of the collar
118 cooperates with the outer surface 156 of the medical article 150 to
inhibit both lateral and
transverse movement of the medical article 150.
[0108] FIGURE 27 is a perspective view of a securement system 300
according to
another preferred embodiment of the present invention. The securement system
300
generally includes a retainer 304 and a clamp 306 which include interengaging
structure. The
body of the retainer 304 includes a longitudinally-extending channel 308 which
is configured
to receive at least a portion of a medical article. The channel 308 can have a
constant or
variable cross section, such as a taper, along a portion or all of its length,
and can be
configured to roughly match the cross section of the portion of the medical
article which it is
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adapted to retain. The channel 308 can extend through an arc of greater than
180 , so as to
provide a degree of snap-fit between the retainer 304 and the medical article.
The channel
308 has a longitudinal access opening 309 located on an underside of the
retainer 304, to
allow ingress or egress of the medical article. To facilitate placement of the
medical article in
the channel 308, the retainer 304 can include one or more features, such as a
depression
above the channel 308 and/or a groove disposed within the channel 308, which
effectively
thin a wall of the retainer 304 near the channel 308 to provide some degree of
flexibility
about the opening 309. The medical article can be installed or removed from
the underside of
the retainer via this access opening 309. Such an arrangement allows the
medical provider to
align at least a portion of the medical article with the retainer 304 prior to
fixing the retainer
to the patient's skin near an insertion site 380 (indicated by the "X" in
FIGURE 27).
101091 The illustrated retainer 304 includes two supports 310(a), 310(b)
disposed
on a lower portion of the retainer 304. The supports 310(a), 310(b) can be
disposed at a
position lower than the access opening 309, so as to limit or prevent contact
of the retained
portion of the medical article with the skin of the patient. The supports
310(a), 310(b) are
disposed on a pair of anchor pads 312(a), 312(b). The supports 310(a), 310(b)
and the
anchor pads 312(a), 312(b) are spaced apart so as to allow ingress and egress
of the medical
article therebetween. The anchor pads 312(a), 312(b) can have an adhesive
disposed on their
undersides so as allow attachment of the pads 312(a), 312(b) to the skin of a
patient. In the
illustrated embodiment, the arrows on the retainer 304 point in the direction
toward the
insertion site (i.e., in the proximal direction).
[0110] The retainer 304 also includes wings 313(a), 313(b) that extend
laterally
from either side of the body of the retainer 304 to form two slots 314(a),
314(b), one on each
side of the retainer 304. The slots 314(a), 314(b) are configured to receive
and engage with
at least portion of the clamp 306, as will be described in further detail
below. In the
illustrated embodiment, the wings 313(a), 313(b) extend in a longitudinal
direction for only a
portion of the longitudinal length of the retainer 304. The slots 314(a),
314(b) extend
through the length of the wings 313(a), 313(b) and are angled slightly
downward in the
proximal direction. Each slot 314(a), 314(b) has a length sufficient to
support an arm 316(a),
316(b) of the clamp 306 and maintain the angle of the clamp 306 with respect
to the retainer
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304 (and thus, with respect to the skin of the patient) when the clamp 306 is
engaged with the
retainer 304.
[0111] The clamp 306 includes two arms 316(a), 316(b), at least a portion
of each
arm being configured for insertion into the slots 314(a), 314(b) and
engagement with a
locking tooth 330(a), 330(b) on the retainer 304. The arms 316(a), 316(b) are
connected at
their distal ends by a collar 318. The collar can be configured to at least
partially surround a
distal portion of the medical article, either loosely or closely, to thereby
form a receiving
channel 370 for the distal portion of the medical article. In some
embodiments, the collar can
be configured to provide some degree of snap-fit with a distal portion of the
medical article.
The collar can be configured to extend through an arc of less than about 180 ,
up to about
180 , or more than 1800, depending on the application. The collar 118 has an
access opening
372 at its underside which is sized at least large enough to receive a distal
portion of the
medical article into the receiving channel 370 of the collar.
[0112] The collar 318 includes a proximally-facing surface 320 which is
configured to abut a corresponding, distally-facing surface of the medical
article when it is
received in the retainer 304 and the clamp 306 is tightened toward the
retainer 304, so as to
inhibit longitudinal movement of the medical article in at least a distal
direction. The collar
318 also includes a curved, inwardly-facing surface 322 which is configured to
contact a
radially outwardly-facing surface of the medical article when the medical
article is secured in
the system 300. The surface 322 can extend about the medical article through
an arc of less
than, about, or greater than 180 so as to inhibit lateral and/or transverse
motion of the
medical article to the extent desired. Each of the arms 316(a), 316(b)
includes one or more
ratchet teeth 324 which are configured to engage corresponding structure of
the retainer 304,
as will be described in further detail below.
[0113] As can be seen in FIGURE 28, the retainer also includes two beams
328(a), 328(b). Each beam 128(a), 128(b) is disposed laterally of the channel
106, near the
slots 314(a), 314(b). The illustrated beams 328(a), 328(b) are cantilevered
beams that extend
from a distal portion of the retainer 304 toward a proximal portion of the
retainer 304. The
beams 328(a), 328(b) can be configured to flex with respect to the portion of
the retainer 304
to which they are attached, so as to facilitate engagement and/or
disengagement of the clamp
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306 with the retainer 304. Each beam 328(a), 328(b) includes one or more
locking teeth
330(a), 330(b) at or near its proximal end. When the arms 316(a), 316(3) of
the clamp 306
are inserted through the corresponding slots 3I4(a), 314(b) of the retainer
304, the ratchet
teeth 324 and the locking teeth 330(a), 330(b) cooperate with the slots
314(a), 314(b) to
adjustably secure the longitudinal position of the clamp 306 with respect to
the retainer 304.
The arms 316(s), 316(b) also cooperate with the slots 314(a), 314(b) to
generally fix the angle
of the clamp 306 with respect to the retainer 304 (see FIGURE 33). In the
illustrated
embodiment, the arms 316(a), 316(b) extend from the collar 318 generally
parallel to one
another. In some embodiments, the arms extend at an angle, toward each other
or apart from
each other in a generally longitudinal direction.
[0114] FIGURES 29 and 30 are top and bottom plan views, respectively, of
the
clamp 306 and retainer 304 shown in FIGURE 27. As can be seen in FIGURE 30,
the
channel 308 includes a distally-facing abutment surface comprising two
abutment surfaces
326(a), 326(b) separated by a narrow groove. At least one of the abutment
surfaces 326(a),
326(b) is configured to abut a corresponding, proximally-facing surface of the
medical article
when the medical article is received in the channel 308 and when the clamp 306
is ratcheted
toward the retainer 304, so as to inhibit longitudinal movement of the
retained medical article
in at least a proximal direction.
[01151 FIGURES 31 through 33 show front, rear, and side views,
respectively, of
the clamp 306 and retainer 304 of FIGURE 3. As most clearly shown in FIGURE
33, an axis
of the central channel 308 lies at an angle 0 with respect to the base
surfaces of the retainer
304. The desired angle 0 between the medical article and the patient is
created by angling the
axis of the central channel 308. This angle is selected in order to align the
axis of the channel
308 of the retainer with the desired incident angle with which the medical
article is to contact
the skin of the patient. A variety of different angles can be used, ranging
from 00 to 45 , and
more preferably from 50 to 25 . For instance, for the securement of
intravenous catheters, it
is desirable for the angle of incidence or 0 of the catheter to the skin of
the patient to be
between about 7 to about 150. For the securement of arterial catheters, it is
desirable for the
angle of incident of the catheter to the skin of the patient to be about
12.50. By angling the
axis of the channel 308 at the desired angle 0, which will depend upon the
particular
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securement application (e.g., securing an arterial catheter, an intravenous
catheter, etc.), the
proper angle of incidence for a catheter can be maintained.
[0116] FIGURE 34 is a
top cross-sectional view through the securement system
300 of FIGURE 33 and shows the teeth 324 of each clamp arm 316(a), 3 I6(b)
facing a
laterally-extending locking tooth 330(a), 330(b) on the retainer 304. The
clamp arms 316(a),
316(b) can be configured such that their proximal ends are spaced apart by a
dimension
slightly shorter than a dimension of the retainer 304. By such a
configuration, the clamp
arms 316(a), 316(b) can slightly pinch the retainer 304 when they are engaged
with the
retainer 304. The retainer 304 can optionally include one or more tracks or
guides to help
guide the clamp 306, and/or to help maintain the angle of the clamp 306 with
respect to the
insertion site, as the clamp 306 moves in a longitudinal direction.
[0117] As also
illustrated in FIGURE 34, the clamp 306 can include one or more
stops 332 disposed at or near the proximal ends of the clamp arms 316(a),
316(b). The stops
332 can be configured to cooperate with one or more protrusions or surfaces on
the retainer
304 (for example, proximally-facing surfaces of either or both wings 313(a),
313(b)) to
inhibit longitudinal distal movement of the clamp beyond a particular position
if or when the
clamp 306 is loosened from the retainer 304.
[0118] FIGURES 35 and
36 show front and rear perspective views, respectively,
of the retainer 304 of FIGURE 29. FIGURES 37 and 38 show top and bottom plan
views,
respectively, of the retainer 304 of FIGURE 29. FIGURES 39 through 41 show
front, rear,
and side views, respectively, of the retainer 304 of FIGURE 29.
[0119] FIGURE 42 is a
cross-sectional view of the retainer 304 taken through line
42-42 of FIGURE 37 and shows an abutment surface 326(b) configured to abut
against a
surface of a secured medical article. Although the channel 308 can be formed
in various
shapes depending upon the desired application (e.g., depending upon a shape of
the retained
portion of the medical article for which the retainer is designed to be used),
the channel 308
desirably has a sufficient length in the longitudinal direction to stabilize
the connector fitting,
catheter hub, or other medical article, rather than act as a fulcrum for the
fitting. That is, the
retainer 304 is configured to receive a sufficient length of the medical
article to inhibit
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movement of the article in the lateral, longitudinal and transverse direction
(i.e., to inhibit
yaw, pitch and axial movement of the article).
[0120] FIGURE 43 is a
top perspective view of the clamp 306 from FIGURE 29
without the retainer 304 and shows a series of teeth 324 on each arm 316 that
engage with the
beam 328 illustrated in FIGURE 34. FIGURE 44 is a bottom perspective view of
the clamp
306 of FIGURE 29. As can be seen in these figures, the clamp 306 can include
one or more
protrusions or motion stops 332 configured to cooperate with a corresponding
surface of the
retainer 304 to inhibit longitudinal movement of the clamp 306 beyond a
particular position
(in the distal direction) when the clamp 306 is loosened from the retainer
304. Such an
arrangement can serve to keep the clamp 306 and the retainer 304 from
completely separating
from one another even after they are loosened from one another.
[0121] FIGURES 45 and 46
are top and bottom plan views, respectively, of the
clamp of FIGURE 43 and show the inwardly extending ratchet teeth 324 and the
outwardly
extending motion stop 332 on each clamp arm 316(a), 316(b). FIGURE 46 shows
the
inwardly-facing surface 322 of the clamp 306. FIGURES 47 and 48 are rear and
front views,
respectively, of the clamp 306 of FIGURE 43 and show the collar 318 disposed
so as to abut
a surface of a secured medical article. FIGURE 48 shows the proximally-facing
surface 320
of the clamp 306.
[0122] FIGURE 49 is an
exploded perspective view of the embodiment shown in
FIGURE 27, shown with an exemplary medical article 302 prior to being received
in the
retainer 304. As can be seen in FIGURE 49, the access opening of the collar
118 is aligned
with the access opening 308 of the retainer 304 along the longitudinal axis,
to allow
placement of proximal and distal portions of the medical article 302 in the
securement system
300. The medical article 302 includes a catheter hub 360 having a stepped-
taper profile and a
connector fitting 362 including a spin nut 364. The illustrated medical
article has a
proximally-facing surface 350, a distally-facing surface 352, and an outwardly-
facing surface
354. In the illustrated embodiment, the step in the taper of the catheter hub
360 forms the
proximally-facing abutment surface 350. The rear surface of the spin nut 364
forms the
distally-facing surface 352, and the outer surface of the distal portion of
the connector fitting
362 forms the outwardly-facing surface 354. Alternatively or in addition, the
tapered
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surfaces of the catheter hub 360 can act as an abutment surface. For example,
the channel
308 forms a stepped taper that generally corresponds to the stepped taper of
the catheter hub
360 of the medical article 302. Thus, when the medical article 302 is placed
in the
securement system 300, the abutment surfaces 326(a), 326(b), as well as the
inner tapering
surfaces of the channel 308 (see FIGURE 38), serve to inhibit longitudinal
movement of the
medical article in the proximal direction.
[0123] In embodiments in which at least a portion of the catheter hub has
a
tapered profile, an inner surface of the tapered channel alone can act as an
abutment surface.
In embodiments in which the catheter hub has a generally cylindrical profile,
the retainer
channel can include an inwardly-extending protrusion or ridge, a tapering or
stepped inner
surface, or any other suitable structure configured to abut the corresponding
surface(s) of the
catheter hub and inhibit longitudinal movement of the medical article in the
proximal
direction.
[0124] FIGURE 50 shows the exemplary medical article 302 received in the
channel 308 of the retainer 304, with the clamp arms 316(a), 316(b) engaged
with the retainer
304 but prior to advancement of the arms 316(a), 316(b). In this position, the
abutment
surfaces 326(a), 326(b) inside the channel 308 (see FIGURE 30) cooperate with
the
proximally-facing surface 350 of the medical article 302 to inhibit
longitudinal movement of
the article 302 in a proximal direction (toward the insertion site 380) beyond
a desired
position.
[0125] FIGURE 51 shows the clamp 306 engaged with the retainer 304, with
the
two parts tightened together about the medical article 302. The collar 318
partially surrounds
a distal portion of the medical article 302. In the illustrated secured
position, the proximally-
facing surface 320 of the collar 318 cooperates with the distally-facing
surface 352 of the
medical article 302 to inhibit longitudinal movement of the article 302 in a
distal direction
beyond a desired position, and the inwardly-facing surface 322 of the collar
318 cooperates
with the outer surface 354 of the medical article 302 to inhibit both lateral
and transverse
movement of the medical article 302.
[0126] The securement system 300 illustrated in FIGURES 27-34 includes a
mechanism by which the clamp 306 may be easily retracted from the retainer 304
after the
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clamp 306 and retainer 304 have been tightened about a medical article. As can
be seen in
FIGURE 51, the distal ends of the clamp arms 316(a), 316(b) include sections
which are
curved or bent laterally outward. A medical provider can release the clamp 306
from the
retainer 304 by pinching on the curved portions, thereby causing the proximal
ends of the
clamp arms 316(a), 316(b) to pivot about the distal ends of the retainer and
separating the
ratchet teeth 324 from the locking teeth 330(a), 330(b).
[0127] Although the embodiment illustrated in FIGURES 27-34 includes
ratchet
teeth on the clamp arms and locking teeth on the retainer, alternative
embodiments can of
course include a reverse configuration in which ratchet teeth are provided on
the retainer and
one or more locking teeth are provided on an arm or arms of the clamp. Of
course, the clamp
and the retainer can include any other suitable corresponding structure that
allows relative
motion of the clamp and the retainer in a longitudinal direction, while
providing securement
of their relative positions as desired.
[01281 FIGURE 52 is a perspective view of a securement system 200 and
medical
article 202 according to another preferred embodiment of the present invention
and shows
another interengagement structure between the arms 212 of the clamp 206 and
the retainer
204 that differs from that which is shown in FIGURE 1. The system 200 is shown
with
anchor pads 201(a), 201(b) and is illustrated securing an exemplary medical
article 202. The
securement system 200 includes a retainer 204 and a clamp 206. A portion of
the retainer
204 forms a channel 208 which is configured to receive at least a portion of
the medical
article 202 prior to the securement system 200 being attached to the skin of a
patient near an
insertion site 280 (indicated by an "X" in FIGURE 52). The clamp 206 includes
two clamp
arms 212 that are connected at a distal portion of the clamp 206 by a collar
214. A plurality
of vertically-extending ratchet teeth 220 are disposed on proximal ends 218 of
the clamp
arms 212, on inward-facing surfaces of the clamp arms 212. FIGURE 53 is a top
plan view
of the system 200 shown without the medical article 202, and better
illustrates the profile of
the clamp arms 212 and the ratchet teeth 220. As can be seen in FIGURE 54, in
the
illustrated embodiment, the clamp 206 is configured to engage with the
retainer 204 so that it
sits at an angle 0 (which may be, for example, about 70) with respect to a
lower surface 230
of the retainer (see FIGURE 56) and thus, with respect to an insertion site on
the skin of the
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patient. The illustrated clamp 206 is also configured to engage with the
retainer 204 so that
the clamp arms 212 are generally aligned with a central axis of the channel
208. In other
embodiments, all or portions of the clamp can be configured to engage with the
retainer so
that the clamp extends at any other angle with respect to the lower surface of
the retainer,
and/or with respect to an axis of the retainer channel.
[0129] FIGURE 55 is a top cross-sectional view through the securement
system
200 of FIGURE 54 and shows the teeth 220 of each clamp arm 212 facing a
laterally-
extending protrusion 222 on the retainer 204. As can also be seen in FIGURE
55, the
channel 208 includes at least one distally-facing abutment surface 210. The
distally-facing
abutment surface 210 is configured to cooperate with a corresponding surface
of the medical
article 202 so as to inhibit movement of the medical article 202 beyond a
desired proximal
position. The collar 214
includes at least one proximally-facing abutment surface 216
which is configured to cooperate with a corresponding surface of the medical
article 202 so
as to inhibit movement of the medical article 202 beyond a desired distal
position. The collar
214 also includes at least one inward-facing (and/or downward-facing) surface
which is
configured to cooperate with a corresponding outer (and/or upper) surface of a
portion of the
medical article 202 so as to inhibit movement of the medical article 202 in a
lateral and/or
transverse direction when the clamp 206 is engaged with the retainer 204.
[0130] The proximal
ends 218 of the clamp arms 212 can be generally straight
sections which are provided with vertically-oriented ratchet teeth 220. The
ratchet teeth 220
cooperate with laterally-extending protrusions 222 on the retainer 204 (see
FIGURE 56) to
engage the clamp 206 with the retainer 204 and set the longitudinal position
of the clamp 206
with respect to the retainer 204. The clamp arms 212 can be configured such
that their
proximal ends 218 are spaced apart by a dimension slightly shorter than a
dimension of the
retainer 204. By such a configuration, the clamp arms 212 slightly pinch the
retainer 204
when they are engaged with the retainer 204. The retainer 204 can optionally
include one or
more vertically-oriented tracks or guides to help guide the clamp 206, and/or
to help maintain
the angle of the clamp 206 with respect to the insertion site, as the clamp
206 moves in a
longitudinal direction.
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[0131] The distal ends 224 of the clamp arms 212 can include sections
which are
curved or bent laterally outward. A medical provider can release the clamp 206
from the
retainer 204 by pinching on the curved portions, thereby causing the proximal
ends 218 of the
clamp arms to pivot about the distal ends 226 of the retainer and separating
the ratchet teeth
220 from the protrusion 222.
[0132] In these and other embodiments, the retainer and/or the clamp can
comprise two separate molded parts. The retainer and clamp can be tethered
together or
otherwise coupled, if so desired. The retainer and clamp can comprise any
suitable material
offering the desired degree of rigidity (and flexibility) for each part,
including, without
limitation, a stiff but somewhat flexible plastic, such as a polycarbonate.
The anchor pads
can comprise any suitable material, including, without limitation, paper,
foam, or a flexible
fabric such as tricot as described above.
[0133] The various embodiments of securement devices and techniques
described
above thus provide a number of ways to provide safe and stable securement for
medical
articles to the skin of a patient. In addition, the techniques described may
be broadly applied
for use with a variety of medical lines and medical procedures.
[0134] Of course, it is to be understood that not necessarily all such
objectives or
advantages may be achieved in accordance with any particular embodiment using
the systems
described herein. Thus, for example, those skilled in the art will recognize
that the systems
may be developed in a manner that achieves or optimizes one advantage or group
of
advantages as taught herein without necessarily achieving other objectives or
advantages as
may be taught or suggested herein.
[0135] Furthermore, the skilled artisan will recognize the
interchangeability of
various features from different embodiments. Although these techniques and
systems have
been disclosed in the context of certain embodiments and examples, it will be
understood by
those skilled in the art that these techniques and systems may be extended
beyond the
specifically disclosed embodiments to other embodiments and/or uses and
obvious
modifications and equivalents thereof. Additionally, it is contemplated that
various aspects
and features of the invention described can be practiced separately, combined
together, or
substituted for one another, and that a variety of combination and
subcombinations of the
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features and aspects can be made and still fall within the scope of the
invention. Thus, it is
intended that the scope of the systems disclosed herein disclosed should not
be limited by the
particular disclosed embodiments described above.
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